WASHINGTON—The the Center for Science in the Public Interest has added two forms of caramel color to its hit list of food colors, claiming that “caramel coloring used in Coca-Cola, Pepsi, and other foods is contaminated with two cancer-causing chemicals and should be banned.” The CSPI filed a regulatory petition with the FDA “to bar the use of caramel colorings produced with ammonia and containing the carcinogens 2-methylimidazole and 4-methylimidazole,” and revoke the two colorants GRAS (Generally Regarded as Safe) status.

Currently the Code of Federal Regulations says “caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice,” and does not distinguish between the four different classes of caramel color. CSPI has requested that FDA ban the use of ammonia- and ammonia-sulfite-process caramel colorings that contain 2-methylimidazole and 4-methylimidazole, both of which, the group says caused lung, liver, or thyroid cancer or leukemia in laboratory mice or rats according to government research. Class III Caramel Color is processed with ammonium compounds and is often used in baking, beer, soy sauce, gravy, and other products. Class IV Caramel Color, or acid-proof caramel, is processed with with ammonium-containing and sulfite-containing compounds and is often formulated into colas and other soft drinks, blended whiskey, and other general food applications.

“Carcinogenic colorings have no place in the food supply, especially considering that their only function is a cosmetic one,” said CSPI executive director Michael Jacobson. “The FDA should act quickly to revoke its approval of caramel colorings made with ammonia.”

The scientists that support CSPI’s petition noted that the State of California’s Office of Environmental Health Hazard Assessment is considering a requirement that products that expose people to more than 16 micrograms (μg) per day of 4-methylimidazole (4-MI, or 4-MEI) carry a Proposition 65 cancer warning notice. They noted a 12-ounce can of cola contains more than 100 μg 4-MI.

The CSPI also noted in the petition that the National Toxicology Program has found low levels of these compounds in several food products, including soy sauce, Worcestershire sauce and wine, but did not say whether they were naturally occurring or from added caramel color. The CSPI also said the amount of sugar in a non-diet can of soda presents a greater health risk than the ammonia-sulfite-process caramel.

The American Beverage Association issued a statement in response to the CSPI’s petition to ban these two types of caramel color, saying: “4-MEI is not a threat to human health. There is no evidence that 4-MEI causes cancer in humans. No health regulatory agency around the globe, including the Food and Drug Administration, has said that 4-MEI is a human carcinogen. This petition is nothing more than another attempt to scare consumers by an advocacy group long-dedicated to attacking the food and beverage industry.”

JunkScience.com also responded to CSPI’s claim that the caramel coloring used in soft drinks like Coca-Cola, Pepsi and other foods is contaminated with cancer-causing chemicals, saying: “CSPI's claim is based on studies in which laboratory rats were given extremely high doses of 2-methylimidazole (2-MI) and 4-methylimidazole (4-MI). But such studies are entirely unreliable indicators of cancer-causing affects in humans, simply because lab rats are not little people…. Moreover, even assuming for the sake of argument that the rat studies were relevant to cancer risk in humans, JunkScience.com calculates that a person would have to consume about 154,000 20-ounce bottles of cola per day to be exposed to the same dose of 4-MI as the lab rats. This is obviously impossible.”

FDA has drafted regulations that establish standards for growing, harvesting, packing and holding

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